A Randomized Trial Of BEAM Plus PBSCT Versus Single Agent High-Dose Therapy Followed By BEAM Plus PBSCT In Patients With Relapsed Hodgkin's Disease
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 88
- 主要终点
- Efficacy at 3 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Compare the efficacy of induction chemotherapy followed by combination chemotherapy and autologous peripheral blood stem cell transplantation with or without high-dose sequential chemotherapy in terms of freedom from treatment failure in patients with relapsed Hodgkin's lymphoma.
- Compare the toxicity of these regimens in these patients.
- Compare the complete remission/unconfirmed complete remission rate at 3 months, relapse-free survival, and overall survival of patients treated with these regimens.
- Compare the frequency of severe toxic effects and secondary neoplasia in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, type of relapse (early first relapse [remission duration 3-12 months] vs late first relapse [remission duration more than 12 months] vs second relapse without prior high-dose chemotherapy salvage [remission duration after salvage at least 3 months]), disease status at relapse (stage I or II vs stage III or IV), age (18 to 49 vs 50 to 60), and response after 2 courses of study induction chemotherapy (complete remission vs partial remission vs no change).
All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18, cisplatin IV continuously over 24 hours on days 1 and 15, cytarabine IV over 3 hours every 12 hours on days 2 and 16, and filgrastim (G-CSF) subcutaneously (SC) once daily on days 5-12 and days 19-26. Patients with complete remission (CR), unconfirmed CR, partial remission, or no change are randomized to one of two treatment arms.
- Arm I: Patients receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 37 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 37-40. Patients also receive G-CSF SC twice daily beginning on day 41 and continuing until blood counts recover. Autologous peripheral blood stem cells (PBSCs) are reinfused on day 42.
- Arm II: Patients receive high-dose cyclophosphamide IV over 8 hours on day 37, high-dose methotrexate IV over 6 hours and high-dose vincristine IV on day 51, and high-dose etoposide IV over 8 hours on days 58-61. Patients then receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 80 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 80-83. Patients also receive G-CSF SC once on days 38 and 62 and twice daily beginning on day 84 and continuing until blood counts recover. Autologous PBSCs are reinfused on day 85.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed Hodgkin's lymphoma
- •Early or late first relapse
- •Complete or partial remission for at least 3 months after completion of prior COPP/ABVD, COPP/ABV/IMEP, MOPP/ABV, ABVD, BEACOPP, or other polychemotherapy regimen with or without radiotherapy
- •No prior salvage therapy OR
- •Second relapse
- •Any prior salvage therapy
- •No prior high-dose chemotherapy
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100% OR
- •Life expectancy:
- •More than 3 months with treatment
- •Hematopoietic:
- •Absolute neutrophil count at least 2,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Not specified
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No uncontrolled hypertension (diastolic blood pressure greater than 115 mm Hg)
- •No unstable angina
- •No New York Heart Association class III or IV heart disease (congestive heart failure)
- •No myocardial infarction within the past 6 months
- •No uncontrolled atrial or ventricular cardiac arrhythmias
- •No chronic pulmonary disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No active infection
- •No poorly controlled diabetes
- •No cerebral disorder
- •No other concurrent malignancy except adequately treated basal cell skin cancer or cervical intraepithelial neoplasia
- •No significant non-malignant disease
- •No psychiatric, addictive, or other disorder that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •Not specified
- •At least 6 months since prior coronary angioplasty
- •No other concurrent investigational drugs
- •No concurrent non-steroidal anti-inflammatory drugs, salicylate, sulfonamide, trimethoprim, allopurinol, aminoglycoside, amoxicillin, or probenecid during high-dose methotrexate administration
排除标准
- 未提供
结局指标
主要结局
Efficacy at 3 months
Toxicity at 3 months
次要结局
- Complete remission at 3 months
- Overall survival at 3 months
- Relapse-free survival at 3 months